Many research studies involve humans as subjects. In studies in medicine, people may be given experimental medications and treatments that are still under study. Psychologists perform experiments to test people’s reactions to certain conditions. Educators try new programs or teaching methods. While these types of studies vary in their level of potential harm to subjects in the study, they all involve, in one way or another, something that could harm the subjects, physically or mentally.
To protect people from harm, there are guidelines that must be followed to ensure ethical treatment of humans in research studies. Guidelines for the ethical treatment of subjects in medical research are described in the National Institute of Health (NIH) brochure Research Ethics: How to Treat People who Participate in Research. More detailed information can be found on the NIH Research Involving Human Subjects website. The principles described here can also be applied to other fields of study.
Seven Basic Research Ethics Guidelines
There are seven basic tenets of protecting human subjects in research:
- Social Value: The study should improve people’s health and well-being, either directly or by increasing the body of knowledge in the field of study. A component of social value is sharing the results of the study with the broader community of researchers in that field and with the public.
- Scientific Validity: The research should be expected to produce useful results and increase knowledge. The study should follow the scientific method and be planned carefully to answer a specific research question. Bias in the research, purposeful or not, ruins the validity of the study and needs to be avoided as much as possible. No research project is perfect, but researchers should design their studies to be as good as they possibly can make them.
- Fair Subject Selection: Researchers should be fair in recruiting and selecting subjects for the study. Researchers must carefully consider the research question and determine which people can best help answer it. Sometimes, random selection is best; sometimes, selection based on specific attributes is best.
- Favorable Risk-Benefit Ratio: Researchers must carefully assess the benefit to the subjects and/or society against the risks the subjects take by participating in the study. The correlation is a positive one: If the risk is high, the benefit must also be high. But if the benefit to the patient or society is low, then the risk to the subjects must be low.
- Independent Review: Any study involving human subjects needs to be independently reviewed by people not connected to the research. This review aims to limit the risk to the subjects in light of the benefit of the research and to be sure the methods are sound and protect the subjects to the greatest extent possible. An independent review of the study also aids in building people’s confidence in the humane treatment of the subjects of the research project.
- Informed Consent: Potential participants in a research study must be told about the details of the study. They must give informed consent before participating. To give informed consent, a subject must:
- be competent (able to understand the facts about the research and make a decision based on the facts);
- be given full disclosure as to what they must do if they participate and what the benefits and risks are, as well as what their other options are;
- show they understand the disclosure fully;
- voluntary agree to participate in the study. People who are not competent or are not old enough to give informed consent can still be participants in research if their legal guardians give the consent.
- Respect for Subjects: During the study, researchers must check on the well-being of the subjects in the study and remove them if the risk is too great for them to continue to participate. Subjects must also be allowed to voluntarily leave the study. All information about subjects in the study must be kept confidential, and subjects must be given the results of the study if they want them.
Institutional Review Boards
All organizations that sponsor research – including universities and other schools, hospitals and professional organizations – have institutional review boards (IRB) that must review all research projects that involve human subjects that fall under the auspices of that organization.
The researcher must submit his research proposal to the IRB, make modifications (if any) based on the IRB’s findings, and keep the IRB informed of any changes or special situations (such as an injury to a subject) that occur while the research is being carried out. The IRB has the right (and responsibility) to stop a research project at any time if it believes the subjects are at greater risk than originally approved.
There are different levels of review, generally based on the level of risk to the subjects.
The lowest level is no review. This is an exemption status and is usually seen for research using existing data, educational research using standard educational procedures and other research that poses no risk to the subjects.
An expedited review is one in which there is very minimal risk to subjects. This status is often granted by the IRB member who conducts the initial review of the proposal if he/she determines that the full IRB does not need to review it.
The highest level is full review in which the entire IRB reads and discusses the proposal. The IRB members may require modifications to the research methods in light of protecting the subjects. Research studies under the purview of full IRB review often have to give periodic updates to the IRB and make modifications as specified by the IRB.
As a researcher, it is important to remember that you must protect your subjects and that your institution or sponsoring organization must be informed as to what your research entails. Before moving forward with any research, check the IRB guidelines for your regulating body. If the research process and processing of data interest you, you may want to consider a degree in the data science field.